Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults

NCT04191837 | Completed

• 1 other identifier: Self-Acup KneeOA
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial comparing the short-term and medium-term effect of self-administered and knee health education for relieving knee pain in middle-aged and older adults with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain severity numerical rating scale

  a single 11-point numeric scale ranges from 0 (no pain) to 10 (greatest pain imaginable) to indicate the pain severity in recent one week.

  Week 4

Secondary Outcomes (5)

• Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  Baseline, Week 4, Week 8, Week 12

• Short Form 6D (SF-6D)

  Baseline, Week 4, Week 8, Week 12

• Timed Up & Go Test (TUG)

  Baseline, Week 4, Week 8, Week 12

• Fast Gait Speed (FGS)

  Baseline, Week 4, Week 8, Week 12

• Pain severity numerical rating scale

  Week 8, Week 12

Other Outcomes (1)

• Self-report frequency of pain medication use

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

Self-administered acupressure

EXPERIMENTAL

A training course will be offered to subjects in this group to train them to perform self-acupressure.

Other: Self-administered acupressure treatment group

Knee health education

ACTIVE COMPARATOR

A course regarding knee health will be offered to the subjects in this group.

Other: Knee health education control group

Interventions

Self-administered acupressure treatment group OTHER

Subjects in the self-administered acupressure exercise group will receive two training sessions (2 hours each, 1-week apart). The self-administered acupressure treatment protocol was developed based on Chinese medicine meridian theory by previous studies and modified. The acupoints are indicated for knee pain and have been commonly used and tested for feasibility in pilot study. The training will be conducted in a group format with 4-6 subjects per group. Each subject will then receive a handout and an acupressure log. They will be told to perform the self-acupressure twice per day for 12 weeks.The capability of participants for self-administered acupressure will be inspected by the instructor with a competency checklist in each session. And a demonstration video will be sent to the participants via WhatsApp for their reference at home.

Self-administered acupressure

Knee health education control group OTHER

Subjects in the health education control group will receive knowledge related to knee OA symptom management. The health education will be conducted in a talk format for 2 hours for two sessions. The course content is developed from the course materials from the websites of Elderly Health Service, Department of Health, Hong Kong SAR and reviewed. Subjects in knee health education group will be told to follow the knee health instruction for 12 weeks.

Knee health education

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ethnic Chinese;
• aged 50 years or above;
• ability to comprehend Chinese;
• fulfilling any 3 of the following criteria: i. morning stiffness ≤ 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity for OA knee diagnosis);
• having knee pain for at least 3 months;
• Knee pain ≥3 on a Likert pain scale from 1-10;
• having a smartphone (or a family member living together having a smartphone) that is compatible to WhatsApp (it is the investigator's experience in the pilot study that most of every subject had been used to using WhatsApp for social communication);
• willing to provide informed consent

You may not qualify if:

• medical diagnoses or conditions that preclude individuals from active participation (e.g. bleeding disorders, alcohol or drug abuse);
• knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, rheumatism) as screened according to the red flags for further investigation or referral in the NICE 2014 Guidelines for Osteoarthritis of the knee;
• score \< 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent understanding of training instructions;
• body mass index over 30, the obese II criteria for Asians (it will be too difficult for the obese subjects to perform acupressure on the acupoints as physical pressure reaching the muscle is required);
• presence of skin lesions or infections at the treatment sites;
• ever had knee replacement surgery;
• pregnancy or contemplating pregnancy;
• ever received acupressure or steroid injection for knee pain over the past 6 months

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• Yeung WF, Chen SC, Cheung DST, Wong CK, Chong TC, Ho YS, Suen LKP, Ho LM, Lao L. Self-Administered Acupressure for Probable Knee Osteoarthritis in Middle-Aged and Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245830. doi: 10.1001/jamanetworkopen.2024.5830.

  PMID: 38639940 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wing-Fai Yeung

  School of Nursing, the Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: December 10, 2019
• Study Start: August 19, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: April 15, 2024

Record last verified: 2020-07

Locations

HK (1)